NIKP-Montelukast

Chronic treatment & prophylaxis of asthma in ped patients 6-14 yr, including prevention of day- & nighttime symptoms; treatment of aspirin-sensitive asthmatic patients & prevention of exercise-induced bronchoconstriction. Symptomatic relief of day- & nighttime allergic rhinitis (seasonal allergic rhinitis) in ped patients 6-14 yr.

Mild persistent asthma 5 mg once daily. Moderate to severe asthma 5 mg once daily w/ inhaled corticosteroids in the evening. Allergic rhinitis 5 mg once daily in the evening.

May be taken with or without food.

Hypersensitivity.

Not to be used for acute asthma attacks. Do not abruptly substitute for inhaled or oral corticosteroids. Neuropsychiatric events. Monitor patients who have experienced eosinophilia, vasculitis rash, worsening pulmonary symptoms, cardiac complications, &/or neuropathy (Churg-Strauss syndrome). Pregnancy & lactation. Childn <6 mth.

Headache. Upper resp infection; increased bleeding tendency, thrombocytopenia; hypersensitivity reactions including anaphylaxis, hepatic eosinophilic infiltration; agitation including aggressive behavior or hostility, anxiousness, depression, disorientation, attention disturbance, dream abnormalities, dysphemia (stuttering), hallucinations, insomnia, memory impairment, obsessive-compulsive symptoms, psychomotor hyperactivity (including irritability, restlessness & tremor), somnambulism, suicidal thinking & behavior (suicidality), tic; dizziness, drowsiness, paraesthesia/hypoesthesia, seizure; palpitations; epistaxis, pulmonary eosinophilia; diarrhea, dyspepsia, nausea, vomiting; increased ALT & AST, hepatitis (including cholestatic, hepatocellular & mixed-pattern liver injury); angioedema, bruising, erythema multiforme, erythema nodosum, pruritus, rash, urticaria; arthralgia, myalgia including muscle cramps; enuresis in childn; asthenia/fatigue, edema, pyrexia.

Decreased AUC w/ phenobarb.

Antiasthmatic & COPD Preparations

R03DC03 - montelukast ; Belongs to the class of leukotriene receptor antagonists. Used in the systemic treatment of obstructive airway diseases.

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